Hycamtin

(Topotecan)

ApprovedSmall molecule

Topotecan is used to treat certain types of cancer, including ovarian cancer, small cell lung cancer, and cervical cancer. It works by stopping cancer cells from dividing and growing.[2] Hycamtin is currently approved and in use across 34 indications[4].[1]

Hycamtin is one of 546 small molecule programs targeting Paraganglioma. It is currently in Approved.

Indications

223

Total Trials

Active Trials

545

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

ParagangliomaApproved

Lung CancerCompleted

Cervical AdenocarcinomaApproved

LeukemiaApproved

Wilms TumorApproved

NeuroblastomaActive, not recruiting

Aseptic MeningitisApproved

Malignant Colon NeoplasmApproved

RetinoblastomaTerminated

Malignant GliomaRecruiting

ParagangliomaApproved

Approved

Lung CancerPhase 3

Completed

Cervical AdenocarcinomaApproved

Approved

LeukemiaApproved

Approved

Wilms TumorApproved

Approved

NeuroblastomaPhase 3

Active, not recruiting

Aseptic MeningitisApproved

Approved

Malignant Colon NeoplasmApproved

Approved

RetinoblastomaPhase 3

Terminated

Malignant GliomaPhase 1

Recruiting

Showing 10 of 34 indications

Competition

Competitive Landscape

235 competitors in Acute Myeloid Leukemia

#DrugCompanyPhaseTrials

Idamycin

Pfizer

Phase 3

60 2

Novantrone

Pfizer

Phase 3

34 3

Fludara

Sanofi

Phase 3

18 4

Cerubidine

HHikma Pharmaceuticals LLC

Phase 3

42 5

Vanflyta

Daiichi Sankyo

Phase 3

16 6

Hycamtin

MMeitheal

Approved

3 7

Cerubidine

HHikma Pharmaceuticals LLC

Phase 3

32 8

Neupogen

EEastern Cooperative Oncology Group

Phase 3

30 9

Nexavar

Cellcept

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Recruiting

Refractory Solid Tumors

NCT05521984

Phase 1Active, not recruiting

Neuroblastoma

NCT02298348

Phase 2Not yet recruiting

Endometrial Cancer

NCT06548763

Phase 3Recruiting

Ovarian Cancer

NCT06394492

Q1 2027

PreclinicalActive, not recruiting

Fallopian Tube Clear Cell Adenocarcinoma

NCT02502266

Q3 2027

Phase 2Not yet recruiting

Neuroblastoma

NCT05303727

Clinical

Trials by Indication[1]

Small Cell Lung Cancer33 trials

LCL161 Plus Topotecan for Patients With Relapsed/Refractory Small Cell Lung Cancer and Select Gynecologic Malignancies

Terminated·SSCRI Development Innovations, LLC·Phase 1·NCT02649673·34 enrolled

Study of Anlotinib Hydrochloride Capsule in Subjects With Small Cell Lung Cancer

Unknown status· Chia Tai Tianqing Pharmaceutical Group Co., Ltd. logo

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Phase 3·NCT04073550·184 enrolled

The Study Of An Oral Drug Called A Radiation Sensitizer In Patients With Newly Diagnosed Small Cell Lung Cancer (SCLC)

Completed· GSK logo

GSK·Phase 2·NCT00043862·60 enrolled

Show 30 more trials

A Study Comparing BL-B01D1 With Topotecan in Patients With Recurrent Small Cell Lung Cancer

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT06500026·714 enrolled

Weekly Topotecan in the Second-Line Treatment of Small Cell Lung Cancer

Completed·SSCRI Development Innovations, LLC·Phase 2·NCT00193388·100 enrolled

Topotecan and Carboplatin in the First-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer

Completed·SSCRI Development Innovations, LLC·Phase 2·NCT00305942·61 enrolled

Study Comparing ZG006 With Investigator-Selected Chemotherapy in Participants With Relapsed Small Cell Lung Cancer

Recruiting·SSuzhou Zelgen Biopharmaceuticals Co.,Ltd·Phase 3·NCT07189455·420 enrolled

Weekly Topotecan in the First-line Treatment of Elderly Patients With Small Cell Lung Cancer

Completed·SSCRI Development Innovations, LLC·Phase 2·NCT00193401·40 enrolled

Immunotherapy as Second-line in Patient With Small Cell Lung Cancer

Completed·IIntergroupe Francophone de Cancerologie Thoracique·Phase 2·NCT03059667·73 enrolled

Cabazitaxel Compared to Topotecan for the Treatment of Small Cell Lung Cancer

Completed· Sanofi logo

Sanofi·Phase 2·NCT01500720·179 enrolled

Study Comparing Amrubicin Versus Topotecan in Patients With Small Cell Lung Cancer Who Have Responded to Prior Therapy.

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT00319969·76 enrolled

Pembrolizumab vs Topotecan in Patients With Small Cell Lung Cancer

Terminated·AAlliance Foundation Trials, LLC.·Phase 2·NCT02963090·9 enrolled

Dinutuximab and Irinotecan Versus Irinotecan to Treat Subjects With Relapsed or Refractory Small Cell Lung Cancer

Completed· United Therapeutics logo

United Therapeutics·Phase 2/3·NCT03098030·483 enrolled

A Study of MHB088C Injection Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer

Recruiting· Qilu Pharmaceutical Co., Ltd. logo

Qilu Pharmaceutical Co., Ltd.·Phase 3·NCT06954246·450 enrolled

M7824 and Topotecan or Temozolomide in Relapsed Small Cell Lung Cancers

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT03554473·37 enrolled

Active Symptom Control Alone Or In Combination With Oral Topotecan In Patients With Relapsed Resistant Small Cell Lung Cancer

Completed· GSK logo

GSK·Phase 3·NCT00276276·141 enrolled

Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Completed·EEastern Cooperative Oncology Group·Phase 2·NCT00057837·140 enrolled

Study of LY01610 in Patients With Recurrent Small Cell Lung Cancer

Recruiting· Luye Pharma Group Ltd. logo

Luye Pharma Group Ltd.·Phase 3·NCT06128837·686 enrolled

Nab-paclitaxel Versus Topotecan As Second-Line Treatment for Patients With Extensive Stage Small Cell Lung Cancer

Unknown status·—·Phase 2·NCT04213937·386 enrolled

Organoid-guided vs Topotecan Therapy in Relapsed Extensive-Stage Small Cell Lung Cancer

Not yet recruiting·PPeking Union Medical College Hospital·Phase 2/3·NCT07106528·128 enrolled

Study of AT-101 in Combination With Topotecan in Relapsed/Refractory Small Cell Lung Cancer

Completed·AAscenta Therapeutics·Phase 1/2·NCT00397293·36 enrolled

A Randomized Study to Compare the Efficacy and Safety of Belotecan and Topotecan as Monotherapy for Sensitive-Relapsed Small Cell Lung Cancer

Completed· Chong Kun Dang Pharmaceutical logo

Chong Kun Dang Pharmaceutical·Phase 2·NCT01497873·164 enrolled

Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer

Active, not recruiting· Amgen logo

Amgen·Phase 3·NCT05740566·509 enrolled

AMR PH GL 2007 CL001 Phase 3 Trial in Patients With Small Cell Lung Cancer After Failure of First-Line Chemotherapy

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT00547651·637 enrolled

JK-1201I Compared with Topotecan in Patients with Relapsed Extensive Stage Small Cell Lung Cancer

Not yet recruiting·JJenKem Technology Co., Ltd.·Phase 3·NCT06581380·394 enrolled

First-line Treatment Of Subjects With Extensive Disease Small Cell Lung Cancer With Weekly Hycamtin And Paraplatin

Completed· GSK logo

GSK·Phase 2·NCT00316186·33 enrolled

Study Comparing Rovalpituzumab Tesirine Versus Topotecan in Subjects With Advanced or Metastatic Small Cell Lung Cancer With High Levels of Delta-like Protein 3 (DLL3) and Who Have First Disease Progression During or Following Front-line Platinum-based Chemotherapy (TAHOE)

Completed· AbbVie logo

AbbVie·Phase 3·NCT03061812·444 enrolled

Study of Irinotecan Liposome Injection (ONIVYDE®) in Patients With Small Cell Lung Cancer

Completed· Ipsen logo

Ipsen·Phase 3·NCT03088813·491 enrolled

Efficacy and Safety of Aldoxorubicin Compared to Topotecan in Subjects With Metastatic Small Cell Lung Cancer

Completed·IImmunityBio, Inc.·Phase 2·NCT02200757·135 enrolled

Phase I Study of Weekly Topotecan in Combination With Sorafenib in Treatment of Relapsed Small Cell Lung Cancer

Completed·HHealthPartners Institute·Phase 1·NCT00466232·16 enrolled

A Phase 2 Study Comparing TAS-102 Versus Topotecan or Amrubicin to Treat Small Cell Lung Cancer Following Platinum-Based Chemotherapy

Terminated· Taiho Oncology, Inc. logo

Taiho Oncology, Inc.·Phase 2·NCT01904253·18 enrolled

Weekly Topotecan With Docetaxel in Recurrent Small Cell Lung Cancer

Terminated·AAultman Health Foundation·Phase 2·NCT00315211·7 enrolled

ARTEMIS-008：A Multicenter, Randomized, Open-label, Phase 3 Study of HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer After Platinum-based First-line Chemotherapy

Completed·HHansoh BioMedical R&D Company·Phase 3·NCT06498479·461 enrolled

Ovarian Cancer26 trials

Oxaliplatin and Topotecan in Advance Ovarian Cancer

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT00313612·39 enrolled

Veliparib and Topotecan for Relapsed Ovarian Cancer With Negative or Unknown BRCA Status

Completed·VVejle Hospital·Phase 1/2·NCT01690598·22 enrolled

Study of NMS-03305293 in Adult Patients With Relapsed Ovarian Cancer

Recruiting·NNerviano Medical Sciences·Phase 1·NCT06930755·24 enrolled

Show 23 more trials

AURELIA: A Study of Avastin (Bevacizumab) Added to Chemotherapy in Patients With Platinum-resistant Ovarian Cancer

Completed· Roche logo

Roche·Phase 3·NCT00976911·361 enrolled

A Phase III Study of BD0801 Combined With Chemotherapy in Recurrent, Platinum-resistant Epithelial Ovarian Cancer

Completed· Jiangsu Simcere Pharmaceutical Co., Ltd. logo

Jiangsu Simcere Pharmaceutical Co., Ltd.·Phase 3·NCT04908787·421 enrolled

Efficacy Study of Chemotherapy to Treat Ovarian Cancer Recurrence by Prolonging the Platinum Free Interval

Unknown status·NNational Cancer Institute, Naples·Phase 3·NCT00657878·215 enrolled

Hycamtin Plus Carboplatin Versus Established Regimens for the Treatment of Ovarian Cancer Relapse

Completed·NNorth Eastern German Society of Gynaecological Oncology·Phase 3·NCT00437307·550 enrolled

SHR-A1921 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer

Recruiting· Suzhou Suncadia Biopharmaceuticals Co., Ltd. logo

Suzhou Suncadia Biopharmaceuticals Co., Ltd.·Phase 3·NCT06394492·440 enrolled

Taxol® in Monotherapy or in Combination With Topotecan or Carboplatin in Patients With Epithelial Ovarian Cancer in Early Relapse

Completed·AARCAGY/ GINECO GROUP·Phase 2·NCT00189566·165 enrolled

Belotecan Versus Topotecan for Recurrent Ovarian Cancer: A Randomized, Open-label, Parallel-group Phase IIb Trial

Completed· Chong Kun Dang Pharmaceutical logo

Chong Kun Dang Pharmaceutical·Phase 2·NCT01630018·141 enrolled

Real-World Effectiveness of Bevacizumab Based on AURELIA in Platinum-resistant Recurrent Ovarian Cancer

Completed·YYonsei University··NCT03367182·50 enrolled

JSKN003 in Platinum-Resistant, Relapsed Epithelial Ovarian Cancer

Not yet recruiting·JJiangsu Alphamab Biopharmaceuticals Co., Ltd·Phase 3·NCT06751485·430 enrolled

Paclitaxel, Carboplatin, and Topotecan in Patients With Ovarian Cancer

Completed·AAGO Study Group·Phase 3·NCT00102375·900 enrolled

HS-20089 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer

Recruiting·HHansoh BioMedical R&D Company·Phase 3·NCT06855069·468 enrolled

Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients

Completed·PPharmaMar·Phase 3·NCT02421588·442 enrolled

REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator's Choice (IC) Chemotherapy in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1

Terminated·SSutro Biopharma, Inc.·Phase 2/3·NCT05870748·600 enrolled

Karenitecin Versus Topotecan in Patients With Advanced Epithelial Ovarian Cancer

Completed·BBioNumerik Pharmaceuticals, Inc.·Phase 3·NCT00477282·509 enrolled

Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer (ARTISTRY-7)

Terminated·MMural Oncology, Inc·Phase 3·NCT05092360·456 enrolled

Weekly Topotecan Therapy in Patients With Ovarian Cancer

Terminated·WWeill Medical College of Cornell University·Phase 2·NCT00194935·32 enrolled

Second-Line Therapy Study For Potentially Platinum-Sensitive Relapsed Ovarian Cancer

Completed· GSK logo

GSK·Phase 2·NCT00316173·77 enrolled

Sorafenib + Topotecan for Platinum-Resistant Recurrent Ovarian Cancer

Terminated·—·Phase 1/2·NCT00526799·30 enrolled

Topotecan Weekly Versus Topotecan Day 1-5 in Patient With Platin-resistant Ovarian Cancer

Completed·NNorth Eastern German Society of Gynaecological Oncology·Phase 2·NCT00170677·194 enrolled

A Phase 1b Study of Sevacizumab in Combination With Chemotherapy in Chinese Patients With Platinum-Resistant Recurrent Ovarian Cancer.

Unknown status· Jiangsu Simcere Pharmaceutical Co., Ltd. logo

Jiangsu Simcere Pharmaceutical Co., Ltd.·Phase 1·NCT03763123·48 enrolled

BI 6727 (Volasertib) Randomised Trial in Ovarian Cancer

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT01121406·110 enrolled

Pertuzumab in Platinum-Resistant Low Human Epidermal Growth Factor Receptor 3 (HER3) Messenger Ribonucleic Acid (mRNA) Epithelial Ovarian Cancer (PENELOPE)

Completed· Roche logo

Roche·Phase 3·NCT01684878·208 enrolled

Topotecan With Erlotinib for Topotecan Pretreated Ovarian Cancer

Terminated·NNYU Langone Health·Phase 2·NCT01003938·6 enrolled

Neuroblastoma9 trials

Study of Efficacy and Safety of Ribociclib (LEE011) in Combination With Topotecan and Temozolomide (TOTEM) in Pediatric Patients With Relapsed or Refractory Neuroblastoma and Other Solid Tumors

Terminated· Novartis logo

Novartis·Phase 1·NCT05429502·12 enrolled

Evaluation of 2 Intensification Treatment Strategies for Neuroblastoma Patients With a Poor Response to Induction

Terminated·GGustave Roussy, Cancer Campus, Grand Paris·Phase 2·NCT03165292·34 enrolled

Activity Study of Bevacizumab With Temozolomide ± Irinotecan for Neuroblastoma in Children

Active, not recruiting·UUniversity of Birmingham·Phase 2·NCT02308527·225 enrolled

Show 6 more trials

Sorafenib and Cyclophosphamide/Topotecan in Patients With Relapsed and Refractory Neuroblastoma

Active, not recruiting·NNew Approaches to Neuroblastoma Therapy Consortium·Phase 1·NCT02298348·18 enrolled

Neuroblastoma Protocol 2008: Therapy for Children With Advanced Stage High Risk Neuroblastoma

Terminated·SSt. Jude Children's Research Hospital·Phase 2·NCT00808899·4 enrolled

Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03786783·42 enrolled

A Multi-Arm, Platform Trial For Relapsed Neuroblastoma

Recruiting·UUniversity of Birmingham·Phase 1/2·NCT07334301·160 enrolled

Allogeneic Hematopoietic Stem Cell Transplantation for 4/M Neuroblastoma

Not yet recruiting·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 2·NCT05303727·64 enrolled

High-Risk Neuroblastoma Chemotherapy Without G-CSF

Completed·—·N/A·NCT02786719·13 enrolled

Cervical Cancer8 trials

A Study of Adavosertib (MK-1775) in Combination With Topotecan/Cisplatin in Participants With Cervical Cancer (MK-1775-008)

Terminated· Merck & Co. logo

Merck & Co.·Phase 1/2·NCT01076400·7 enrolled

Phase II Study of Pazopanib and Topotecan in Cervical Cancer

Withdrawn·MM.D. Anderson Cancer Center·Phase 2·NCT02348398

Topotecan, Cisplatin and Bevacizumab for Recurrent/Persistent Cervical Cancer

Completed·WWashington University School of Medicine·Phase 2·NCT00548418·27 enrolled

Show 5 more trials

Safety and Tolerability Evaluation Study of BVAC-C in Patients With HPV Type 16 or 18 Positive Cervical Cancer

Completed·CCellid Co., Ltd.·Phase 1/2·NCT02866006·32 enrolled

Balstilimab Versus Investigator Choice Chemotherapy in Patients With Recurrent Cervical Cancer (BRAVA)

Withdrawn·AAgenus Inc.·Phase 3·NCT04943627

Efficacy Study of Weekly Topotecan With Cisplatin in Advanced Stage or Recurrent Cervical Cancer

Terminated·UUniversity of Alabama at Birmingham·Phase 1·NCT00322920·30 enrolled

Study of Adjuvant Topotecan and Cisplatin With Concurrent Radiation Therapy for Advanced Cervical Cancer

Completed·UUniversity of New Mexico·Phase 1·NCT00320983·11 enrolled

Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer

Completed· Pfizer logo

Pfizer·Phase 3·NCT04697628·502 enrolled

Lung Cancer6 trials

Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT02481830·569 enrolled

Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus CAV or Topotecan as Treatment in Patients With Small-Cell Lung Cancer

Completed·PPharmaMar·Phase 3·NCT02566993·613 enrolled

Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer

Completed·SSCRI Development Innovations, LLC·Phase 2·NCT00294190·38 enrolled

Show 3 more trials

Dose Attenuated Chemotherapy in Compromised Patients With Lung Cancer

Recruiting·FFox Chase Cancer Center·Phase 2·NCT05800587·280 enrolled

Berzosertib + Topotecan in Relapsed Platinum-Resistant Small-Cell Lung Cancer (DDRiver SCLC 250)

Completed· EMD Serono Research & Development Institute, Inc. logo

EMD Serono Research & Development Institute, Inc.·Phase 2·NCT04768296·76 enrolled

Topotecan Plus Apatinib Versus Topotecan Alone as Second-line Therapy in Small-cell Lung Cancer

Unknown status·—·Phase 2·NCT02980809·60 enrolled

77 more indications

Retinoblastoma4 trials

High-dose Topotecan for Retinoblastoma With Recurrent or Refractory Vitreous Seed

Recruiting·EEye & ENT Hospital of Fudan University·Phase 1·NCT06972602·10 enrolled

A Prospective International Multicenter Clinical Trial for Eyes With Relapsed Retinoblastoma

Terminated·—·Phase 2·NCT04455139·2 enrolled

Topotecan and Melphalan for Retinoblastoma

Recruiting·SSun Yat-sen University·Phase 3·NCT04799002·50 enrolled

Show 1 more trial

Phase I Trial of Periocular Topotecan in Retinoblastoma

Completed·HHospital JP Garrahan·Phase 1·NCT00460876·5 enrolled

Glioma4 trials

Topotecan Using Convection-Enhanced Delivery (CED) in High Grade Glioma

Completed·MMichael Vogelbaum, MD, PhD·Phase 1·NCT02278510·3 enrolled

Topotecan in Glioma Undergoing A Clinically-Indicated Surgical Resection

Terminated·MMichael Vogelbaum, MD, PhD·Phase 1·NCT02500459·9 enrolled

Intratumorally-Administered Topotecan Using Convection-Enhanced Delivery in Patients With Grade III/ IV Glioma

Terminated·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT03927274·3 enrolled

Show 1 more trial

Intratumorally-Administered Topotecan Using CED in High Grade Glioma Undergoing Stereotactic Biopsy

Withdrawn·MMichael Vogelbaum, MD, PhD·Phase 1·NCT03193463

Fallopian Tube Cancer4 trials

Topotecan and Gefitinib (Iressa) for Ovarian, Peritoneal, or Fallopian Tube Cancer

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT00317772·19 enrolled

A Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Women With Folate Receptor (FR) Alpha Positive Advanced Epithelial Ovarian Cancer (EOC), Primary Peritoneal or Fallopian Tube Cancer

Completed·IImmunoGen, Inc.·Phase 3·NCT02631876·366 enrolled

A Study of Mirvetuximab Soravtansine vs. Investigator's Choice (IC) of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha (FRα) Expression

Completed· AbbVie logo

AbbVie·Phase 3·NCT04209855·453 enrolled

Show 1 more trial

Trial on Trabectedin (ET-743) vs Clinician's Choice Chemotherapy in Recurrent Ovarian, Primary Peritoneal or Fallopian Tube Cancers of BRCA Mutated or BRCAness Phenotype Patients

Completed·FFondazione Policlinico Universitario Agostino Gemelli IRCCS·Phase 3·NCT02903004·242 enrolled

Chemotherapy3 trials

A Study of ALRN-6924 for the Prevention of Chemotherapy-induced Side Effects (Chemoprotection)

Terminated·AAileron Therapeutics, Inc.·Phase 1·NCT04022876·35 enrolled

SCLC on the 2nd Line With Relapsed After Response to Chemotherapy GFPC 01-2013

Unknown status·UUniversity Hospital, Angers·Phase 3·NCT02738346·164 enrolled

Trilaciclib (G1T28) in Patients With Previously Treated Extensive Stage SCLC Receiving Topotecan Chemotherapy

Completed·GG1 Therapeutics, Inc.·Phase 1/2·NCT02514447·123 enrolled

Advanced Solid Tumors3 trials

Open-label Study of Topotecan and Pazopanib in Advanced Solid Tumors

Completed· GSK logo

GSK·Phase 1·NCT00732420·68 enrolled

Weekly Topotecan in Combination With Carboplatin in Two Different Schedules for Refractory and/or Advanced Solid Tumors

Completed·SSCRI Development Innovations, LLC·Phase 1·NCT00193583·18 enrolled

Topotecan in Combination With Docetaxel in Refractory and/or Advanced Solid Tumors

Completed·SSCRI Development Innovations, LLC·Phase 1·NCT00193570·20 enrolled

Endometrial Cancer3 trials

Oral Topotecan With Toripalimab for Patients With Endometrial Cancer

Not yet recruiting·FFudan University·Phase 2·NCT06548763·30 enrolled

Study of the Weekly Oral RAD001 in Combination With Oral Topotecan in Patients With Advanced or Recurrent Endometrial Cancers

Completed·YYale University·Phase 1·NCT00703807·10 enrolled

Intravenous Weekly Topotecan In Subjects With Recurrent Or Persistent Endometrial Cancer

Completed· GSK logo

GSK·Phase 2·NCT00267488·70 enrolled

Non-Small Cell Lung Cancer3 trials

Oral Topotecan Versus Intravenous Docetaxel In Pretreated, Advanced Non-Small Cell Lung Cancer

Completed· GSK logo

GSK·Phase 3·NCT00049998·760 enrolled

Oral Topotecan Versus Docetaxel in Second-Line Treatment of Non-Small Cell Lung Cancer

Completed·SSCRI Development Innovations, LLC·Phase 2·NCT00193245·80 enrolled

Concurrent Radiotherapy With Weekly Topotecan for Primary Treatment of Inoperable Localized Non-small Cell Lung Cancer

Completed·UUniversity of New Mexico·Phase 1·NCT00322751·10 enrolled

Multiple Myeloma3 trials

Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT00005792·131 enrolled

TMC (Topotecan, Cyclophosphamide and Melphalan) for Multiple Myeloma

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01039025·60 enrolled

Study of Melphalan and Topotecan (MT) Followed by Autologous Stem Cell Rescue in Patients With Multiple Myeloma.

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1/2·NCT00325416·177 enrolled

Primary Peritoneal Cancer3 trials

Lapatinib and Topotecan in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Did Not Respond to Cisplatin or Carboplatin

Completed·MMayo Clinic·Phase 2·NCT00436644·18 enrolled

Trial on NIraparib-TSR-042 (Dostarlimab) vs Physician's Choice CHEmotherapy in Recurrent, Ovarian, Fallopian Tube or Primary Peritoneal Cancer Patients Not Candidate for Platinum Retreatment

Unknown status·FFondazione Policlinico Universitario Agostino Gemelli IRCCS·Phase 3·NCT04679064·427 enrolled

Cisplatin Induction With Paclitaxel Consolidation for Stage III-IV Epithelial Ovarian and Primary Peritoneal Cancer

Completed·JJohn P. Fruehauf·Phase 2·NCT00314678·40 enrolled

Solid Tumors3 trials

Topotecan, Ifosfamide and Carboplatin in Children and Young Adults With Solid Tumors

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT00502892·2 enrolled

Berzosertib Human Mass Balance Study (DDRiver Solid Tumors 208)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT05246111·6 enrolled

Oral Topotecan to Treat Recurrent or Persistent Solid Tumors

Completed·AAccelerated Community Oncology Research Network·Phase 1/2·NCT00382733·26 enrolled

Cervical Carcinoma3 trials

Indirect Comparison Topotecan Cervical Carcinoma

Completed· GSK logo

GSK··NCT01345279·1 enrolled

Weekly IV Topotecan and Cisplatin With Radiation in Cervical Carcinoma

Completed·UUniversity of California, Irvine·Phase 2·NCT00257816·12 enrolled

Phase 1/2a/3 Evaluation of Adding AL3818 to Standard Platinum-Based Chemotherapy in Subjects With Recurrent or Metastatic Endometrial, Ovarian, Fallopian, Primary Peritoneal or Cervical Carcinoma (AL3818-US-002)

Unknown status·AAdvenchen Laboratories, LLC·Phase 3·NCT02584478·294 enrolled

Patients With Advanced Solid Tumors2 trials

A Bioequivalence Study of Two Oral Formulations of Topotecan in Patients With Advanced Solid Tumors

Completed· GSK logo

GSK·Phase 1·NCT00046111·1 enrolled

A Study To Determine If Two Different Versions Of Topotecan Have The Same Potency In Patients With Advanced Solid Tumors

Completed· GSK logo

GSK·Phase 1·NCT00259935·107 enrolled

SCLC2 trials

Study in Patients With SCLC of Veliparib in Combination With Topotecan

Unknown status·CCentral European Society for Anticancer Drug Research·Phase 1·NCT03227016·30 enrolled

A Multicenter, Open-lable, Randomized Phase III Study of PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer

Active, not recruiting·BBiotheus Inc.·Phase 3·NCT06616532·404 enrolled

Lymphoma2 trials

Safety Study of ABT-888 Plus Topotecan Hydrochloride to Treat Patients With Solid Tumors and Lymphomas

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00553189·31 enrolled

A Phase II Study of Paclitaxel and Topotecan With Filgrastim-SD/01 Support For Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00038545·25 enrolled

Refractory2 trials

Topotecan for Irinotecan-Refractory SCLC

Unknown status·GGachon University Gil Medical Center·Phase 2·NCT00502762

Simvastatin With Topotecan and Cyclophosphamide in Relapsed and/or Refractory Pediatric Solid and CNS Tumors

Completed·EEmory University·Phase 1·NCT02390843·13 enrolled

Acute Leukemia2 trials

Use of Topotecan in Patients With Refractory Acute Leukemia

Completed·UUS Department of Veterans Affairs·Phase 2·NCT00100477·10 enrolled

A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Activity of Idasanutlin in Combination With Either Chemotherapy or Venetoclax in Treatment of Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias or Solid Tumors

Terminated· Roche logo

Roche·Phase 1/2·NCT04029688·38 enrolled

Primary Peritoneal Carcinoma2 trials

Study of Lenalidomide With Topotecan In Subjects With Advanced Ovarian and Primary Peritoneal Carcinoma

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1/2·NCT00179712·60 enrolled

Topotecan Plus Paclitaxel and Carboplatin in the Initial Treatment of Advanced Ovarian and Primary Peritoneal Carcinoma

Completed·SSCRI Development Innovations, LLC·Phase 2·NCT00193297·50 enrolled

Peritoneal Cancer2 trials

Efficacy of Topotecan and Lapatinib in Early Recurrent Ovarian or Peritoneal Cancer

Terminated·CCentre Francois Baclesse·Phase 2·NCT00888810·39 enrolled

Second-line Intravenous Treatment For Recurrent Platinum-Sensitive Ovarian, Fallopian, Or Peritoneal Cancer

Completed· GSK logo

GSK·Phase 2·NCT00061308·75 enrolled

Refractory Solid Tumors2 trials

Targeting Pediatric Brain Tumors and Relapsed/Refractory Solid Tumors With Sodium Glucose Cotransporter 2 Inhibitors (SGLT2i)

Recruiting·WWashington University School of Medicine·Phase 1·NCT05521984·20 enrolled

Phase I, Dosage-finding and PK Study of IV Topotecan and Erlotinib With Refractory Solid Tumors

Completed·AAccelerated Community Oncology Research Network·Phase 1·NCT00611468·29 enrolled

Acute Myeloid Leukemia2 trials

Fludarabine, Cytarabine, Topotecan in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Completed·PPETHEMA Foundation·Phase 4·NCT00488709·47 enrolled

Imatinib + MTC in Relapsed / Refractory Acute Myeloid Leukemia (AML)

Completed·GGoethe University·Phase 2·NCT00744081·130 enrolled

Malignancies2 trials

A Phase I Study of CCI-779 (Temsirolimus) in Combination With Topotecan in Patients With Gynecologic Malignancies

Completed·UUniversity of Chicago·Phase 1·NCT00523432·15 enrolled

Sorafenib and Topotecan in Refractory/Recurrent Pediatric Malignancies

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT01683149·13 enrolled

Advanced Malignancies2 trials

Phase IB Study to Evaluate the Safety of Selinexor (KPT-330) in Combination With Multiple Standard Chemotherapy or Immunotherapy Agents in Patients With Advanced Malignancies

Terminated·MM.D. Anderson Cancer Center·Phase 1·NCT02419495·221 enrolled

Topotecan in Combination With Pemetrexed in Patients With Advanced Malignancies

Completed·SSCRI Development Innovations, LLC·Phase 1·NCT00315861·15 enrolled

Platinum-resistant Ovarian Cancer2 trials

A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator's Choice (IC) in Patients With Platinum Resistant Ovarian Cancer

Active, not recruiting· Genmab logo

Genmab·Phase 3·NCT06619236·584 enrolled

A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator's Choice (IC) in Patients With Platinum Resistant Ovarian Cancer

Recruiting· Genmab logo

Genmab·Phase 3·NCT07604766·82 enrolled

Ovarian Neoplasms2 trials

A Randomized, Open-label, Multicenter, Phase 3 Study to Investigate Mocertatug Rezetecan Compared With Standard of Care in Participants With Platinum-resistant Ovarian Cancer

Recruiting· GSK logo

GSK·Phase 3·NCT07286266·450 enrolled

FRAmework-01: A Three-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) Versus Chemotherapy or Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer, and Sofetabart Mipitecan Plus Bevacizumab Versus Platinum-Based Chemotherapy Plus Bevacizumab in Platinum-Sensitive Ovarian Cancer.

Recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT07213804·1,630 enrolled

Safety and Efficacy1 trial

Study of Talazoparib in Combination With Chemotherapy in Relapsed Pediatric AML to Determine Safety and Efficacy

Recruiting·—·Phase 1·NCT05101551·34 enrolled

Induction Chemotherapy1 trial

A Phase I/II Study of Induction Chemotherapy With Daunorubicin, Cytarabine, Topotecan and Etoposide

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1/2·NCT00005793·41 enrolled

Medulloblastoma1 trial

Study of Nifurtimox to Treat Refractory or Relapsed Neuroblastoma or Medulloblastoma

Completed·GGiselle Sholler·Phase 2·NCT00601003·112 enrolled

Pediatric Patients1 trial

9-ING-41 in Pediatric Patients With Refractory Malignancies.

Terminated·AActuate Therapeutics Inc.·Phase 1·NCT04239092·40 enrolled

Malignant Glioma1 trial

Chronic CED of TPT for Recurrent Malignant Glioma

Recruiting·—·Phase 1·NCT06666712·6 enrolled

Clinical Trial1 trial

Treatment Extension Study for Patients Who Have Previously Participated and Have Benefited From Iniparib in a Clinical Trial

Completed· Sanofi logo

Sanofi·Phase 3·NCT01593228·37 enrolled

COVID-191 trial

Reducing Hypoxia in Patients With Coronavirus Disease (COVID-19) Using Topotecan With Standard of Care

Unknown status·NNational University Hospital, Singapore·Phase 1·NCT05083000·24 enrolled

Breast Cancer1 trial

Brain Metastases In ErbB2-Positive Breast Cancer

Terminated· GSK logo

GSK·Phase 2·NCT00437073·22 enrolled

Malignant Brain Tumors1 trial

Phase II Study of Intraventricular Methotrexate in Children With Recurrent or Progressive Malignant Brain Tumors

Terminated·NNicklaus Children's Hospital f/k/a Miami Children's Hospital·Phase 2·NCT02684071·3 enrolled

Ovarian Carcinoma1 trial

Trial of High Dose Topotecan With Carboplatin in Patients With Relapsed Ovarian Carcinoma

Terminated·AAssistance Publique - Hôpitaux de Paris·Phase 1·NCT01177501·3 enrolled

Metastasis1 trial

Phase II Trial of Chemotherapy With Temodar With Topotecan for CNS Metastasis of Solid Tumors

Withdrawn·TThe Methodist Hospital Research Institute·Phase 2·NCT01736800

Relapsed or Refractory1 trial

Clinical Trial of SP-2577 (Seclidemstat) in Patients With Relapsed or Refractory Ewing or Ewing-related Sarcomas

Unknown status·SSalarius Pharmaceuticals, LLC·Phase 1·NCT03600649·50 enrolled

Relapse1 trial

Lurbinectedin or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed SCLC

Recruiting· Luye Pharma Group Ltd. logo

Luye Pharma Group Ltd.·Phase 3·NCT06496048·180 enrolled

Solid Neoplasms1 trial

A Pilot Trial of Oral Topotecan for the Treatment of Refractory Advanced Solid Neoplasms Expressing HIF-1a

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00117013·16 enrolled

Metastatic Colorectal Cancer1 trial

Weekly Topotecan in Patients Treated for Metastatic Colorectal Cancer

Completed·SSCRI Development Innovations, LLC·Phase 2·NCT00193167·40 enrolled

Rectal Cancer1 trial

Oral Topotecan As A Radiosensitizing Agent In Rectal Cancer

Terminated· GSK logo

GSK·Phase 1·NCT00158886·26 enrolled

Clear Cell Carcinoma1 trial

Study Of Nintedanib Compared To Chemotherapy in Patients With Recurrent Clear Cell Carcinoma Of The Ovary Or Endometrium

Unknown status·NNHS Greater Glasgow and Clyde·Phase 2·NCT02866370·120 enrolled

Meningitis1 trial

Phase 1 Intrathecal Topotecan for Neoplastic Meningitis

Completed·—·Phase 1·NCT00674674·22 enrolled

Chronic1 trial

Chronic Convection Enhanced Delivery of Topotecan

Completed·—·Phase 1·NCT03154996·5 enrolled

Oral1 trial

Regulatory Hycamtin(Oral) PMS

Completed· GSK logo

GSK··NCT01037023·92 enrolled

Liposomal Doxorubicin1 trial

Genomic Directed Salvage Chemotherapy With Either Liposomal Doxorubicin Or Topotecan

Terminated·HH. Lee Moffitt Cancer Center and Research Institute·N/A·NCT00720096·4 enrolled

Soft Tissue Sarcoma1 trial

a Multicenter Clinical Trial for the Treatment of Children and Adolescents With Soft Tissue Sarcoma Stage 4

Completed·CCooperative Weichteilsarkom Study Group·Phase 2·NCT00130858·90 enrolled

Rhabdomyosarcoma1 trial

New Therapeutic Strategies for Patients With Ewing's Sarcoma Family of Tumors, High Risk Rhabdomyosarcoma, and Neuroblastoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00001335·90 enrolled

Refractory or Recurrent Solid Tumor1 trial

A Study of SGT-53 in Children With Refractory or Recurrent Solid Tumors

Suspended·SSynerGene Therapeutics, Inc.·Phase 1·NCT02354547·18 enrolled

Patients With Solid Tumors1 trial

ME-344 Given in Combination With Hycamtin® in Patients With Solid Tumors

Terminated·MMEI Pharma, Inc.·Phase 1/2·NCT02100007·46 enrolled

Small Cell Cancer1 trial

Trial of Topotecan With VX-970 (M6620), an ATR Kinase Inhibitor, in Small Cell Cancers and Extrapulmonary Small Cell Cancers

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT02487095·62 enrolled

Advanced Solid Malignancies1 trial

Phase I Study of GW572016 With Topotecan to Treat Advanced Solid Malignancies

Completed·MMayo Clinic·Phase 1·NCT00295243·25 enrolled

Impaired Renal Function1 trial

A Phase I Topotecan Study in Subjects With Cancer and Impaired Renal Function

Completed· GSK logo

GSK·Phase 1·NCT00483860·59 enrolled

Efficacy1 trial

Meta-analysis of Efficacy of Topotecan

Completed· GSK logo

GSK··NCT01160185·1 enrolled

Papilloma1 trial

Intra-Arterial Chemotherapy for Newly Diagnosed, Residual, or Recurrent Atypical Choroid Plexus Papilloma and Choroid Plexus Carcinoma Prior to Second-Look Surgery

Terminated·WWeill Medical College of Cornell University·Phase 1·NCT04994977·1 enrolled

Glioblastoma1 trial

Avastin/Radiation (XRT)/Temozolomide (Temodar) Followed by Avastin/Temodar/Topotecan for Glioblastoma

Completed·—·Phase 2·NCT01004874·80 enrolled

Glioblastoma Multiforme1 trial

Oral Pazopanib Plus Oral Topotecan Metronomic Antiangiogenic Therapy for Recurrent Glioblastoma Multiforme (A) Without Prior Bevacizumab Exposure and (B) After Failing Prior Bevacizumab

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01931098·35 enrolled

Celecoxib1 trial

N2012-01: Phase 1 Study of Difluoromethylornithine (DFMO) and Celecoxib With Cyclophosphamide/Topotecan

Completed·NNew Approaches to Neuroblastoma Therapy Consortium·Phase 1·NCT02030964·30 enrolled

Bevacizumab1 trial

Ph II Study of Wkly Topotecan + Bevacizumab in Plat. Resistant/Recurrent Gyn Cancers

Completed·—·Phase 2·NCT00343044·40 enrolled

PARP Inhibitor1 trial

Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Topotecan

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT00516438·48 enrolled

Recurrent1 trial

Phase I Trial of Oral Metronomic Topotecan and Oral Pazopanib to Treat Recurrent/Persistent Gynecologic Tumors

Completed·VVector Oncology·Phase 1·NCT00800345·33 enrolled

Progressive Multifocal Leukoencephalopathy1 trial

Safety and Effectiveness of Topotecan HCl to Treat HIV-Infected Patients With AIDS-Related Progressive Multifocal Leukoencephalopathy (PML)

Completed· GSK logo

GSK·Phase 2·NCT00002395·54 enrolled

Recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT07437963·76 enrolled

Ganglioneuroblastoma, Nodular1 trial

A Phase 3 Study of Dinutuximab Added to Intensive Multimodal Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma

Recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT06172296·478 enrolled

Neoplasms, Ovarian1 trial

A Phase 2 Open-label Randomized Study of Farletuzumab Ecteribulin (MORAb-202), a Folate Receptor Alpha-targeting Antibody-drug Conjugate, Versus Investigator's Choice Chemotherapy in Women With Platinum-resistant High-grade Serous (HGS) Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT05613088·106 enrolled

Solid Cancer1 trial

A Phase 2/3, Multicenter, Randomized Study of Raludotatug Deruxtecan (R-DXd), a CDH6-directed Antibody-drug Conjugate, in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Preclinical·NCT06161025·860 enrolled

Small Cell Lung Carcinoma1 trial

A Randomized, Multicenter, Open-label, Phase III Study of Lurbinectedin Single-Agent or Lurbinectedin in Combination With Irinotecan Versus Investigator's Choice (Topotecan or Irinotecan) in Relapsed Small Cell Lung Cancer Patients (LAGOON Trial)

Completed·PPharmaMar·Phase 3·NCT05153239·705 enrolled

Neoplasms, Lung1 trial

Phase 3, Multicenter, Randomized, Open-label Clinical Study of GSK5764227, a B7-H3 Antibody Drug Conjugate (ADC), Compared With Topotecan in Participants With Relapsed Small Cell Lung Cancer (SCLC)

Recruiting· GSK logo

GSK·Phase 3·NCT07099898·420 enrolled

Extensive Stage Small Cell Lung Cancer (ES-SCLC)1 trial

A Global, Multicenter, Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Standard of Care (SOC) in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Recruiting· Gilead logo

Gilead·Phase 3·NCT06801834·695 enrolled

Proliferative Vitreoretinopathy1 trial

The Safety and Efficacy of Intravitreal Topotecan for the Treatment of Proliferative Vitreoretinopathy

Not yet recruiting·MMassachusetts Eye and Ear Infirmary·Phase 1·NCT06425419·50 enrolled

Ewing sarcoma1 trial

PHASE 1/2 STUDY TO EVALUATE PALBOCICLIB (IBRANCE®) IN COMBINATION WITH IRINOTECAN AND TEMOZOLOMIDE OR IN COMBINATION WITH TOPOTECAN AND CYCLOPHOSPHAMIDE IN PEDIATRIC PATIENTS WITH RECURRENT OR REFRACTORY SOLID TUMORS

Completed· Pfizer logo

Pfizer·Phase 2·NCT03709680·128 enrolled

Osteosarcoma1 trial

A Phase II Open Label Basket Trial Study Using Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma

Recruiting·MMilton S. Hershey Medical Center·Phase 2·NCT07321912·406 enrolled

Solid Tumor1 trial

An Open-label, Phase 1a/1b, Dose Escalation and Dose Expansion Study Investigating the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of PHST001 in Adult Patients With Advanced Relapsed and/or Refractory Solid Tumors

Recruiting·PPheast Therapeutics·Phase 1·NCT06840886·426 enrolled

Extensive-stage Small-cell Lung Cancer1 trial

A Randomized, Double-Blind, Placebo-Controlled Study of Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan Chemotherapy

Active, not recruiting·PPharmacosmos A/S·Approved·NCT05874401·302 enrolled

Fallopian Tube Clear Cell Adenocarcinoma1 trial

A Randomized Phase II/III Study of the Combination of Cediranib and Olaparib Compared to Cediranib or Olaparib Alone, or Standard of Care Chemotherapy in Women With Recurrent Platinum-Resistant or -Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (COCOS)

Active, not recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT02502266·582 enrolled

Unspecified4 trials

Topotecan Pharmacokinetic Characterization Study

Completed· GSK logo

GSK·Phase 1·NCT00361803·15 enrolled

Study of the Farnesyl Transferase Inhibitor, R115777, in Combination With Topotecan (NYU 99-32)

Unknown status·NNational Center for Research Resources (NCRR)·Phase 1·NCT00006199

Phase I Study of Intrathecal Topotecan

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00001333·30 enrolled

Show 1 more trial

Cabozantinib With Topotecan-Cyclophosphamide

Completed·—·Phase 1·NCT04661852·12 enrolled

Regulatory

FDA Approval Timeline[5]

May 28, 1996

HYCAMTIN

NDA NDA020671

May 28, 1996

HYCAMTIN

NDA NDA020671

Feb 4, 1998

HYCAMTIN

NDA NDA020671

Nov 30, 1998

HYCAMTIN

NDA NDA020671

Jan 18, 2000

HYCAMTIN

NDA NDA020671

Feb 10, 2000

HYCAMTIN

NDA NDA020671

Aug 3, 2001

HYCAMTIN

NDA NDA020671

Mar 6, 2002

HYCAMTIN

NDA NDA020671

Feb 26, 2003

HYCAMTIN

NDA NDA020671

Mar 11, 2003

HYCAMTIN

NDA NDA020671

May 9, 2003

HYCAMTIN

NDA NDA020671

Jun 14, 2006

HYCAMTIN

NDA NDA020671

Oct 11, 2007

HYCAMTIN

NDA NDA020981

Sep 5, 2008

HYCAMTIN

NDA NDA020981

Mar 26, 2010

HYCAMTIN

NDA NDA020671

Mar 26, 2010

HYCAMTIN

NDA NDA020671

Jun 30, 2010

HYCAMTIN

NDA NDA020981

Feb 2, 2011

TOPOTECAN HYDROCHLORIDE

NDA NDA200582

Feb 25, 2011

TOPOTECAN

NDA NDA200199

Oct 7, 2011

HYCAMTIN

NDA NDA020981

Dec 20, 2012

TOPOTECAN HYDROCHLORIDE

NDA NDA022453

Feb 28, 2014

HYCAMTIN

NDA NDA020671

Jun 18, 2014

HYCAMTIN

NDA NDA020981

Jun 2, 2015

HYCAMTIN

NDA NDA020671

Sep 5, 2018

HYCAMTIN

NDA NDA020671

Sep 5, 2018

HYCAMTIN

NDA NDA020981

Oct 8, 2019

HYCAMTIN

NDA NDA020671

Sources

References

[1]
ClinicalTrials.gov — 223 trial records for Topotecan. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Hycamtin drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Topotecan compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Topotecan. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020671). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Meitheal company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: DNA Topoisomerase I Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: MMeitheal

Hycamtin

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q3 2027

Trials by Indication[1]

Small Cell Lung Cancer33 trials

Ovarian Cancer26 trials

Neuroblastoma9 trials

Cervical Cancer8 trials

Lung Cancer6 trials

Retinoblastoma4 trials

Glioma4 trials

Fallopian Tube Cancer4 trials

Chemotherapy3 trials

Advanced Solid Tumors3 trials

Endometrial Cancer3 trials

Non-Small Cell Lung Cancer3 trials

Multiple Myeloma3 trials

Primary Peritoneal Cancer3 trials

Solid Tumors3 trials

Cervical Carcinoma3 trials

Patients With Advanced Solid Tumors2 trials

SCLC2 trials

Lymphoma2 trials

Refractory2 trials

Acute Leukemia2 trials

Primary Peritoneal Carcinoma2 trials

Peritoneal Cancer2 trials

Refractory Solid Tumors2 trials

Acute Myeloid Leukemia2 trials

Malignancies2 trials

Advanced Malignancies2 trials

Platinum-resistant Ovarian Cancer2 trials

Ovarian Neoplasms2 trials

Safety and Efficacy1 trial

Induction Chemotherapy1 trial

Medulloblastoma1 trial

Pediatric Patients1 trial

Malignant Glioma1 trial

Clinical Trial1 trial

COVID-191 trial

Breast Cancer1 trial

Malignant Brain Tumors1 trial

Ovarian Carcinoma1 trial

Metastasis1 trial

Relapsed or Refractory1 trial

Relapse1 trial

Solid Neoplasms1 trial

Metastatic Colorectal Cancer1 trial

Rectal Cancer1 trial

Clear Cell Carcinoma1 trial

Meningitis1 trial

Chronic1 trial

Oral1 trial

Liposomal Doxorubicin1 trial

Soft Tissue Sarcoma1 trial

Rhabdomyosarcoma1 trial

Refractory or Recurrent Solid Tumor1 trial

Patients With Solid Tumors1 trial

Small Cell Cancer1 trial

Advanced Solid Malignancies1 trial

Impaired Renal Function1 trial

Efficacy1 trial

Papilloma1 trial

Glioblastoma1 trial

Glioblastoma Multiforme1 trial

Celecoxib1 trial

Bevacizumab1 trial

PARP Inhibitor1 trial

Recurrent1 trial

Progressive Multifocal Leukoencephalopathy1 trial

Lorlatinib1 trial

Rectal Carcinoma1 trial

Recurrent Ganglioneuroblastoma1 trial

Ganglioneuroblastoma, Nodular1 trial

Neoplasms, Ovarian1 trial

Solid Cancer1 trial